AGX-148 / AgonOx - LARVOL DELTA

CD39+CD103+ Selected CD8+ Tumor Infiltrating Lymphocytes for the Treatment of Solid Tumors (IMMUNOLOGY 2025) - P1 | "T-cell receptor (TCR) sequencing revealed the long-term persistence of T cell clones from AGX-148 drug product in the peripheral blood of patients. These findings highlight AGX-148’s potential as a promising therapeutic option for metastatic solid tumors."

IO biomarker • Tumor-infiltrating lymphocyte • Oncology • Solid Tumor • CD8 • CTLA4 • ENTPD1 • HAVCR2 • ITGAE • PD-1

Tumor-reactive CD8 TIL with an exhausted phenotype can be expanded and regress human tumors (AACR 2024) - P1 | "These preclinical data were the basis for a human clinical trial design for the adoptive transfer of CD8 DP TIL (product termed, AGX148)...Blood draws and tumor biopsies were obtained prior to and after treatment and we are currently assessing the CD8 T cell repertoire (TCRseq) and phenotype from these patient samples. In conclusion, this is the first study showing that CD8 T cells with an exhausted phenotype isolated from human tumors can be expanded to billions and induce tumor regression in vivo."

Late-breaking abstract • Oncology • Solid Tumor • CD8 • CTLA4 • ENTPD1 • HAVCR2 • IL2 • ITGAE • PD-1

Phio Pharmaceuticals Announces Dosing of First Patient in Collaborative Clinical Trial with AgonOx, Inc. and Providence Cancer Institute (GlobeNewswire) - "Phio Pharmaceuticals Corp...today announced that its clinical development partners, AgonOx, Inc. and Providence Cancer Institute of Oregon, have dosed their first patient in an Adoptive Cell Therapy clinical trial...This first-in-human trial is investigating the safety and the potential for enhanced therapeutic benefit from the administration of AgonOx’s AGX148 'double positive' (DP) CD8 tumor-infiltrating lymphocytes (TIL) alone and in combination with Phio's PD-1 silencing PH-762 in patients with melanoma and other advanced solid tumors."

Trial status • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Melanoma • Oncology • Skin Cancer • Solid Tumor

ACT: Adoptive Cell Therapy Using Cancer Specific CD8+ Tumor Infiltrating Lymphocytes in Adult Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: AgonOx, Inc.

Metastases • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Lung Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • BRAF • CD8

Phio Pharmaceuticals Announces Initiation of Collaborative Clinical Trial with PH-762, AgonOx's Tumor Infiltrating Lymphocyte Program (AGX148) and Providence Cancer Institute (PRNewswire) - "Phio Pharmaceuticals Corp...announced its clinical development partner, AgonOx, Inc, in collaboration with Providence Cancer Institute, has completed the site initiation visit and can commence with patient accrual. The clinical trial will assess the safety and the potential for enhanced therapeutic benefit from the administration of Phio's PH-762 treated 'double positive' (DP) CD8 tumor infiltrating lymphocytes (TILs) in patients with melanoma and other advanced solid tumors."

New trial • Melanoma • Oncology • Skin Cancer • Solid Tumor

Phio Pharmaceuticals Reports 2022 Year End Financial Results and Provides Business Update (PRNewswire) - "Upcoming Pipeline Milestones: (i) Plan to commence a U.S. Phase 1b clinical trial with PH-762 focused on the treatment of cutaneous squamous cell carcinoma ('cSCC') and other selected cutaneous malignancies in the second half of 2023; (ii) In partnership with AgonOx, Inc., plan to commence enrollment of subjects in a clinical trial evaluating the use of PH-762 and DP TIL in ACT during the second quarter of 2023."

Enrollment status • New P1 trial • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Phio Pharmaceuticals Announces Regulatory Clearance of Clinical Trial With PH-762 and AgonOx's Tumor Infiltrating Lymphocytes (AGX148) to Treat Solid Tumors (PRNewswire) - "Phio Pharmaceuticals...announced their clinical development partner, AgonOx, Inc. has received confirmation from the FDA that their planned Phase 1 clinical trial in patients with advanced solid tumors may proceed. The initial Phase 1 clinical trial is designed to assess safety and to study the potential for an enhanced therapeutic benefit from the administration of Phio's PH-762 treated 'double positive' (DP) CD8 tumor infiltrating lymphocyte (TIL) in patients with melanoma and other advanced solid tumors....Preclinical data from in-vitro studies using autologous human tumor cells demonstrated that treating AGX148 with Phio's PH-762 increased by two-fold their tumor killing activity. The trial will be conducted at Providence under the leadership of Dr. Weinberg and Principal Investigator Brendan Curti, MD, Medical Oncologist and Robert W. Franz Endowed Chair for Clinical Research."

IND • New P1 trial • Melanoma • Oncology • Solid Tumor

Manufacturing of a clinical scale CD8 TIL product, AGX148, with and without gene silencing of PD-1 using self-delivering RNAi INTASYLTM PH-762 (SITC 2022) - "Conclusions We have generated a potent tumor-specific ACT TIL product (AGX148) at clinical scale through the isolation and selective expansion of tumor-reactive T cells. Knocking down PD-1 with PH-762 INTASYL™ has the potential to further enhance the function of the AGX148 product and this ACT product will soon be tested in cancer patients."

Clinical • IO biomarker • Melanoma • Oncology • Solid Tumor • CD8 • ENTPD1 • ITGAE • PD-1

Phio Pharmaceuticals Announces Study Results at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) on November 10th and 11th (PRNewswire) - 'Phio Pharmaceuticals...announced the results of several studies of its INTASYL™ compounds....The posters will be presented on November 10th and 11th at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), which is being held in Boston, MA from November 8 – 12, 2022."

P1 data • Preclinical • Breast Cancer • Melanoma • Oncology • Solid Tumor

Phio Pharmaceuticals Announces Upcoming Presentations at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (PRNewswire) - "Phio Pharmaceuticals...announced it is scheduled to provide an update on its programs at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), which will be held in Boston, MA from November 8 - 12, 2022. This will include an update on its first-in-human clinical trial with PH-762 in advanced melanoma; data demonstrating the potential of PH-762 to further enhance the function of tumor infiltrating lymphocytes (TILs) with its partner AgonOx, Inc.; and new preclinical data on relevant targets identified in cancer immunotherapy using our INTASYL compounds."

P1 data • Preclinical • Breast Cancer • Melanoma • Oncology • Skin Cancer • Solid Tumor